Analyst Downgrades MannKind On Afresa Concerns

NEW YORK (AP) — An Oppenheimer analyst downgraded shares of MannKind Corp. Friday, questioning how soon the company's insulin candidate Afresa might be approved and how long it might taken MannKind to find a marketing partner.

John Newman downgraded the stock to "Underperform" from "Perform." He said MannKind probably will not be able to get a partner on Afresa by the end of the third quarter, and the Food and Drug Administration may be reluctant to approve the inhaled insulin in January. He suggested the agency may want MannKind to run a study on two inhalers.

The Valencia, Calif., company raised $59.7 million through a stock offering in August. Newman said MannKind would not have raised cash if it expected to enter a partnership and get an upfront cash payment soon.

The analyst noted two possible FDA hurdles for Afresa. He said an FDA advisory panel may want to review the drug in December, but Afresa may not be available for such a review. Newman also said the FDA could ask MannKind to conduct a four-month study comparing its old inhaler, called MedTone, with a new, smaller inhaler called Dreamboat.

The FDA is scheduled to make a ruling on Afresa by Jan. 16.

In morning trading, MannKind shares lost 23 cents, or 2.3 percent, to $10.